Back to resultsA Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Primary Purpose
Immune System Disorder (Healthy Volunteers)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Belumosudil
UGT1A1 victim drug
P-gp victim drug
OATP1B1/BCRP victim drug
Sponsored by
About this trial
This is an interventional basic science trial for Immune System Disorder (Healthy Volunteers)
Eligibility Criteria
Inclusion Criteria: Healthy male participants aged 18 to 55 years old Must agree to use an adequate method of contraception Must be able to understand and provide a written informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria. Failure to satisfy the investigator of fitness to participate for any other reason. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number: 8400001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1
Part 2
Part 3
Arm Description
Belumosudil + UGT1A1 victim drug administered in the fed state
Belumosudil + P-gp victim drug administered in the fed state
Belumosudil + OATP1B1/BCRP victim drug administered in the fed state
Outcomes
Primary Outcome Measures
AUC(0-last)- Parts 1,2, and 3 (victim drugs)
Area under the curve from time 0 to the time of last measurable concentration
AUC(0-inf)- Parts 1,2, and 3 (victim drugs
Area under the curve from time 0 extrapolated to infinity
Secondary Outcome Measures
Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Time of maximum observed concentration.
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Maximum observed concentration
T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Terminal elimination half-life
AUC(0-last)-Part 1 (victim metabolite)
AUC(0-inf)- Part 1 (metabolite of victim drug)
Tmax- Part 1(metabolite of victim drug)
Cmax- Part 1 (metabolite of victim drug)
T1/2- Part 1 (metabolite of victim drug)
AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)
Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3
Area under the curve for the defined interval between doses (tau)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To provide additional safety and tolerability information for belumosudil by assessing: AEs, vital signs, ECGs, physical examinations and laboratory safety tests following administration of the three victim drugs alone and in combination with belumosudil.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05806567
Brief Title
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Official Title
A Three-part, Sequential, Non-randomized, Open-label Study Designed to Evaluate the Effect of Oral Belumosudil on UGT1A1, P-gp, BCRP and OATP1B1 Inhibition in the Fed State in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon, a Sanofi Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male subjects.
Detailed Description
Part 1: The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject.
Part 2: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject.
Part 3: The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Disorder (Healthy Volunteers)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1
Arm Type
Experimental
Arm Description
Belumosudil + UGT1A1 victim drug administered in the fed state
Arm Title
Part 2
Arm Type
Experimental
Arm Description
Belumosudil + P-gp victim drug administered in the fed state
Arm Title
Part 3
Arm Type
Experimental
Arm Description
Belumosudil + OATP1B1/BCRP victim drug administered in the fed state
Intervention Type
Drug
Intervention Name(s)
Belumosudil
Other Intervention Name(s)
REZUROCK/KD025/SAR445761
Intervention Description
Pharmaceutical form: Tablet; Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
UGT1A1 victim drug
Intervention Description
Pharmaceutical form: Tablet; Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
P-gp victim drug
Intervention Description
Pharmaceutical form: Capsule; Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
OATP1B1/BCRP victim drug
Intervention Description
Pharmaceutical form: Tablet; Route of administration: Oral
Primary Outcome Measure Information:
Title
AUC(0-last)- Parts 1,2, and 3 (victim drugs)
Description
Area under the curve from time 0 to the time of last measurable concentration
Time Frame
Multiple timepoints up to approximately 15 days
Title
AUC(0-inf)- Parts 1,2, and 3 (victim drugs
Description
Area under the curve from time 0 extrapolated to infinity
Time Frame
Multiple timepoints up to approximately 15 days
Secondary Outcome Measure Information:
Title
Tmax- Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Description
Time of maximum observed concentration.
Time Frame
Multiple timepoints up to approximately 15 days
Title
Cmax -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Description
Maximum observed concentration
Time Frame
Multiple timepoints up to approximately 15 days
Title
T1/2 -Parts 1, 2, and 3 (victim drugs, belumosudil and belumosudil metabolites)
Description
Terminal elimination half-life
Time Frame
Multiple timepoints up to approximately 15 days
Title
AUC(0-last)-Part 1 (victim metabolite)
Time Frame
Multiple timepoints up to approximately 10 days
Title
AUC(0-inf)- Part 1 (metabolite of victim drug)
Time Frame
Multiple timepoints up to approximately 10 days
Title
Tmax- Part 1(metabolite of victim drug)
Time Frame
Multiple timepoints up to approximately 10 days
Title
Cmax- Part 1 (metabolite of victim drug)
Time Frame
Multiple timepoints up to approximately 10 days
Title
T1/2- Part 1 (metabolite of victim drug)
Time Frame
Multiple timepoints up to approximately 10 days
Title
AUC(0-last) - Parts 1, 2, and 3 (Belumosudil and metabolites)
Time Frame
Multiple timepoints up to approximately 15 days
Title
Area under the curve for the defined interval between doses (tau) [AUC(0 tau)] - Parts 1, 2, and 3
Description
Area under the curve for the defined interval between doses (tau)
Time Frame
Multiple timepoints up to approximately 15 days
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Description
To provide additional safety and tolerability information for belumosudil by assessing: AEs, vital signs, ECGs, physical examinations and laboratory safety tests following administration of the three victim drugs alone and in combination with belumosudil.
Time Frame
Up to 30 days after the administration of last dose of study drug i.e., up to approximately 43 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male participants aged 18 to 55 years old
Must agree to use an adequate method of contraception
Must be able to understand and provide a written informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
Failure to satisfy the investigator of fitness to participate for any other reason.
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number: 8400001
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
We'll reach out to this number within 24 hrs